AZELASTINE HYDROCHLORIDE spray, metered

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X)

Հասանելի է:

Preferred Pharmaceuticals Inc.

Կառավարման երթուղին:

NASAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Azelastine hydrochloride Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. None. Risk Summary Limited data from postmarketing experience over decades of use with azelastine hydrochloride in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. Oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (MRHDID) of 1.096 mg. However, the relevance of these findings in animals to pregnant women was considered questionable based upon the high animal to human dose multiple. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study in mice dosed during the period of organogenesis, azelastine hydrochloride caused embryo-fetal death, structural abnormalities (cleft palate; short or absent tail; fused, absent or branched ribs), delayed ossification, and decreased fetal weight at approximately 300 times the maximum recommended human daily intranasal dose (MRHDID) in adults (on a mg/m2 basis at a maternal oral dose of 68.6 mg/kg/day), which also caused maternal toxicity as evidenced by decreased maternal body weight. Neither fetal nor maternal effects occurred in mice at approximately 15 times the MRHDID in adults (on a mg/m2 basis at a maternal oral dose of 3 mg/kg/day). In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 to 17, azelastine hydrochloride caused structural abnormalities (oligo-and brachydactylia), delayed ossification, and skeletal variations, in the absence of maternal toxicity, at approximately 270 times the MRHDID in adults (on a mg/m2 basis at a maternal oral dose of 30 mg/kg/day). Azelastine hydrochloride caused embryo-fetal death and decreased fetal weight and severe maternal toxicity at approximately 610 times the MRHDID (on a mg/m2 basis at a maternal oral dose of 68.6 mg/kg/day). Neither fetal nor maternal effects occurred at approximately 20 times the MRHDID (on a mg/m2 basis at a maternal oral dose of 2 mg/kg/day). In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, azelastine hydrochloride caused abortion, delayed ossification and decreased fetal weight and severe maternal toxicity at approximately 530 times the MRHDID in adults (on a mg/m2 basis at a maternal oral dose of 30 mg/kg/day). Neither fetal nor maternal effects occurred at approximately 5 times the MRHDID (on a mg/m2 basis at a maternal oral dose of 0.3 mg/kg/day). In a prenatal and postnatal development study in pregnant rats dosed from late in the gestation period and through the lactation period from gestation day 17 through lactation day 21, azelastine hydrochloride produced no adverse developmental effects on pups at maternal doses up to approximately 270 times the MRHDID (on mg/m2 basis at a maternal dose of 30 mg/kg/day). Risk Summary There are no data on the presence of azelastine hydrochloride in human milk, the effects on the breastfed infant, or the effects on milk production. Breastfed infants should be monitored for signs of milk rejection during azelastine hydrochloride use by lactating women (see Clinical Considerations). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for azelastine hydrochloride and any potential adverse effects on the breastfed infant from azelastine hydrochloride or from the underlying maternal condition. Clinical Considerations Monitoring for Adverse Reactions Breastfed infants of lactating women treated with azelastine hydrochloride should be monitored for possible signs of milk rejection related to the bitter taste of azelastine hydrochloride. The safety and effectiveness of Azelastine hydrochloride Nasal Spray for the treatment of symptoms of seasonal allergic rhinitis have been established for patients 5 years and older [see Adverse Reactions (6.1) and Clinical Studies (14.1) ]. The safety and effectiveness of Azelastine hydrochloride Nasal Spray for the treatment of vasomotor rhinitis have been established for patients 12 years and older [see Adverse Reactions (6.1) and Clinical Studies (14.2) ]. The safety and effectiveness of Azelastine hydrochloride Nasal Spray in pediatric patients below the age of 5 years with seasonal allergic rhinitis and in pediatric patients below the age of 12 years with vasomotor rhinitis have not been established. Clinical trials of Azelastine hydrochloride Nasal Spray did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Azelastine Hydrochloride Nasal Spray 0.1% (ay" zel as' teen hye" droe klor' ide) Important: For use in your nose only. For the correct dose of medicine: Figure A identifies the parts of your Azelastine hydrochloride Nasal Spray pump Before you use Azelastine hydrochloride Nasal Spray for the first time, you will need to prime the bottle. Priming your Azelastine hydrochloride Nasal Spray Remove the transparent dust cover over the tip of the pump and the white safety clip just under the “shoulders” of the pump (See Figure B ). Hold the bottle upright with 2 fingers on the shoulders of the spray pump unit and Now your pump is primed and ready to use. Using your Azelastine hydrochloride Nasal Spray Step 1. Blow your nose to clear your nostrils. Step 2. Keep your head tilted downward toward your toes. Step 3. Place the spray tip about ¼ inch to ½ inch into 1 nostril. Hold bottle upright and aim the spray tip toward the back of your nose (See Figure D ). Step 4. Close your other nostril with a finger. Press the pump 1 time and sniff gently at the same time, keeping your head tilted forward and down (See Figure E ). Step 5. Repeat Step 3 and Step 4 in your other nostril. Step 6. If your healthcare provider tells you to use 2 sprays in each nostril, repeat Steps 2  through 4 above for the second spray in each nostril. Step 7. Breathe in gently, and do not tilt your head back after using Azelastine hydrochloride Nasal Spray. This will help to keep the medicine from going into your throat. Step 8. When you finish using your Azelastine hydrochloride Nasal Spray, wipe the spray tip with a clean tissue or cloth. Put the safety clip and dust cover back on the bottle. Cleaning the Spray Tip of your Azelastine hydrochloride Nasal Spray   This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.  Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Revised: 11/2020 Relabeled By: Preferred Pharmaceuticals Inc.

Ապրանքի ամփոփագիր:

Azelastine Hydrochloride Nasal Spray, 137 mcg is supplied as a 30 mL package NDC 68788-8514-2 delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a white safety clip and a transparent dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. After priming [see Dosage and Administration (2.3) ], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. Azelastine Hydrochloride Nasal Spray should not be used after the expiration date “EXP” printed on the medicine label and carton. Storage: Store upright at controlled room temperature 20° to 25°C (68° to 77°F). Protect from freezing.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SPRAY, METERED
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZELASTINE
HYDROCHLORIDE NASAL SPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
AZELASTINE HYDROCHLORIDE NASAL SPRAY.
AZELASTINE HYDROCHLORIDE NASAL SPRAY
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Azelastine hydrochloride Nasal Spray is an H -receptor antagonist
indicated for the treatment of the
symptoms of seasonal allergic rhinitis in adults and pediatric
patients 5 years and older and for the
treatment of the symptoms of vasomotor rhinitis in adults and
adolescent patients 12 years and older. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Azelastine hydrochloride Nasal Spray: 137 mcg of azelastine
hydrochloride in each 0.137 mL spray. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most common adverse reactions (≥2% incidence) are: bitter taste,
headache, somnolence,
dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis,
sinusitis, paroxysmal sneezing, nausea, dry
mouth, fatigue, dizziness, and weight increase. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, AUROBINDO PHARMA USA, INC. AT
1-866-850-2876
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 3/2024
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Seasonal Allergic Rhinitis
1
For intranasal use only (2.3)
Seasonal allergic rhinitis:
•
•
Pediatric patients 5 to 11 years of age: 1 spray per nostril twice
daily (2.1)
Adults and adolescents 12 years of age and older: 1 or 2 sprays per
nostril twice daily (2.1)
Vasomotor rhinitis: 2 sprays per nostril twice daily in adults and
adolescents 12 years of age and older
(2.2)
Prime Azelastine hydrochloride Nasal Spray before initial use and when
it has not been used for 3 o